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A Study to Gather Safety Data Following Administration of a Hib-containing Booster Vaccine in Children Aged Two to Five Years (DIPS)

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ClinicalTrials.gov Identifier: NCT00625118
Recruitment Status : Completed
First Posted : February 28, 2008
Last Update Posted : November 4, 2010
Information provided by:
Public Health England

Brief Summary:

This will be an observational study where parents/ guardians of children in receipt of their preschool booster will be approached for their child(ren) to take part. Following written informed consent the Vaccine Research Nurse will explain the purpose of the study and what would be involved. Participation will involve completion of a health diary for the week following vaccination to document how their child has been both in terms of local reactions and systemic symptoms as well as any visits to a doctor (GP or hospital). The nurse will telephone the family at 48−72 hours following vaccination to see how the child has been. Information about the vaccine given in the current campaign and vaccines administered in the infant schedule including date of administration, product and batch number will be recorded where available.

Should any large local reactions be reported the nurse may visit the child to take a photograph to document and illustrate these - photographs will be taken without the child's face visible.

Subjects will be recruited in two centres - Hertfordshire and Gloucestershire. Recruitment will start as soon as the necessary approvals are in place. Monthly reports of observed data will be submitted to the MHRA though the formal analysis will not be conducted until the end of the study.

Recruitment figures and the incidence of ESLs will be reviewed on a six−monthly basis.

At this point it is difficult to predict parental attitude to taking part, though from experience with recruitment in previous studies it is hoped this will be positive, so affording a large number of participants.

Condition or disease
Haemophilus Infections

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Study to Gather Safety Data Following Administration of a Hib-containing Booster Vaccine in Children Aged Two to Five Years
Study Start Date : December 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Children in receipt of a Hib containing vaccine at pre-school booster (3.5-6 years old).

Information from the National Library of Medicine

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Ages Eligible for Study:   42 Months to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Children in receipt of pre-school booster vaccinations (age 3.5-6 years)

Inclusion Criteria:

  • Child in receipt of the preschool booster vaccination or Menitorix under the Hib catchup campaign
  • Written informed consent from a parent/ guardian

Exclusion Criteria:

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00625118

United Kingdom
Health Protection Agency
Gloucester, United Kingdom
Health Protection Agency
London, United Kingdom
Sponsors and Collaborators
Public Health England
Principal Investigator: Elizabeth Miller, MB BS FFPHM FRCPath Public Health England

Responsible Party: Prof Elizabeth Miller, Health Protection Agency
ClinicalTrials.gov Identifier: NCT00625118     History of Changes
Other Study ID Numbers: DIPS
First Posted: February 28, 2008    Key Record Dates
Last Update Posted: November 4, 2010
Last Verified: January 2009

Keywords provided by Public Health England:
Hib conjugate vaccine
local reactions
systemic symptoms

Additional relevant MeSH terms:
Haemophilus Infections
Pasteurellaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Immunologic Factors
Physiological Effects of Drugs